Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, March 21, 2015

Harm by "innovation" and irrational exuberance: a home grown threat.


“Irrational Exuberance”: A homegrown threat to our nation’s health



Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
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Posted: Friday, March 20, 2015, 9:56 AM FiDA highlight added


Our prevailing model of medical progress, innovation and research centers on the concept of "benefit". Doctors, in both academic and corporate medicine, are focused on developing novel therapies to benefit our patients beyond the existent standards of care. This noble intent has evolved from our profession's desire to heal our patients and to create a healthy society.
Once the benefit of a novel approach is either demonstrated (or agreed upon) by expert consensus, new standards of care are established and funded by our health insurance infrastructure. This is the awesome power of American healthcare and our insurance infrastructure in the 21st century.
However, a very serious and insidious deficit also plagues our optimistic, "benefit-oriented" outlook on innovation and progress in corporate medicine. We do not always place sufficient emphasis on the concept of "harm". That is, in our quest to save lives and innovate, the cost to those who do not benefit is often disregarded or minimized.
We do not focus enough on whether the harm brought about by our 'beneficial advances' could have been avoided - nor do we evaluate the tangible and intangible costs of advancement when we construct our new standards of care.



This tendency to downplay the harm done by innovation, in favor of marketing real or perceived benefit, has turned our healthcare establishment into a self-congratulatory and “irrationally exuberant” one.
So on the backs of those harmed without consideration, we may be on an “irrationally exuberant” path to financial and spiritual ruin in medicine, despite our best intentions. Our financial markets have demonstrated this phenomenon repeatedly over the past three decades in America. As it is said, "the road to hell is paved with good intentions".
Of course, this irrational exuberance in American medicine stands to be dramatically worsened by medicine's corporate nature today. After all there is a lot of money to be made in saving lives. And our health insurance infrastructure is designed to pay for benefit-driven, "life-saving" interventions. Most individuals are willing to pay a high price for the promise of staying alive - no one wants to die.
Of course, our corporations capitalize on this fact. They market and advertise increasingly sophisticated, expensive and "beneficial" therapies. The harm done and its cost is not part of the corporate marketing label - at best, it is a footnote and at worst it is censored.
Corporate forces in medicine are only too willing to use the banner of benefit and safety to acquire revenue and profit. And when there is money to be made, dwelling on the cost of harm, especially if it is to a minority subset of patients, is downplayed and even ridiculed - because it gets in the way of lucrative business and cash flow.
Most tragically, our federal government, whose responsibility it is to protect the forgotten minority of people in harm’s way, seems to have lost its existential purpose. Congress, and our public health agencies, are increasingly influenced by corporate lobby power and special interest groups – not patients and their advocates. Because most of those harmed go home, go bankrupt or die – they very certainly do not lobby lawmakers and federal agencies in any effective manner. And while healthy, most people never imagine themselves being in harm’s way. So not enough people rally behind solid patient safety initiatives and legislative actions proposed by cogent politicians.
Instead of being true to their constitutional mission to protect every American citizen from harm, our federal public health agencies, notably the FDA, have accepted corporate America as being an equal stake-holder to individual citizens and residents of our land. This is a massive regulatory error that has resulted in very notable failures – and these will recur until citizens and legislators of reason and courage drive necessary improvements to our flailing federal system.
As a prominent example, the 510(k) legislation governing approval of the majority of medical devices by the United States Food and Drug Administration does not require any definitive pre-market safety testing and it provides no consistent “risk assessment” mechanism; nor does 510(k) definitively require active surveillance or consistent reporting of adverse outcomes by doctors, hospitals or manufacturers to FDA.
Of course most Americans find these lax safety standards in the medical device industry hard to believe. Some even think our critique is too much of a "blanket statement" about a very complex regulatory process. But it really is that simple: corporate forces have breached the FDA and have deviated its public health and patient safety mission in the medical device space. Most citizens have no idea that this is the case. In fact, most of us trust that our government and our healthcare establishment is there to protect us from harm – but that is simply not a guarantee, especially on issues and practices that are not clearly in the public eye.
Unless, as patients and doctors, we shed our irrational exuberance about medical benefit and the infallibility of our healthcare establishment, and instead empathetically focus on the possibility of harm and its systemic and personal costs…Unless, as citizens, we demand that our federal government realign itself with the people’s interests instead of corporate and special interests…we will continue to accept the unacceptable from the medical establishment and from our federal government.
We may even manage to drive our society’s health and healthcare establishment into irrecoverable bankruptcy - both financial and ethical.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed’s unsuspected uterine cancer was spread by the device during a routine hysterectomy.



Read more at http://www.philly.com/philly/blogs/healthcare/Irrational-Exuberance-A-home-grown-threat-to-our-nations-health.html#FtrFfIsWqQMVcurX.99



Read more at http://www.philly.com/philly/blogs/healthcare/Irrational-Exuberance-A-home-grown-threat-to-our-nations-health.html#qfiOq2L7FXx8VkU7.99

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